Devices, systems, and methods for navigating a biopsy tool to a target location and obtaining a tissue sample using the same

ABSTRACT

A system for performing a surgical procedure includes a bronchoscope, monitoring equipment coupled to the bronchoscope, a tracking system, a positioning assembly, and a biopsy tool. The biopsy tool includes an elongated flexible body extending from a proximal end to a distal end and a biopsy member formed on the distal end of the elongated flexible body. The biopsy member includes a tissue-receiving portion defining an opening including sharpened edges. The sharpened edges are disposed on the interior perimeter of the opening and are capable of cutting tissue. A biopsy tool is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/564,779, filed Dec. 9, 2014, which claims the benefit of the filingdate of provisional U.S. Patent Application No. 61/955,407, filed Mar.19, 2014, the entire contents of each of which are incorporated hereinby reference.

INTRODUCTION

The present disclosure relates to biopsy sampling and, moreparticularly, to devices, systems, and methods for navigating a biopsytool to a target location and obtaining a tissue sample using the biopsytool.

BACKGROUND

A bronchoscope is inserted into a patient's airways through thepatient's nose or mouth. A typical bronchoscope includes an elongatedflexible tube having an illumination assembly for illuminating theregion distal to the bronchoscope's tip, an imaging assembly forproviding a video image from the bronchoscope's tip, and a workingchannel through which instruments, e.g., diagnostic instruments such asbiopsy tools and/or therapeutic instruments such as ablation probes, canbe inserted.

Bronchoscopes are limited in how far they may be advanced through theairways due to their size. Where the bronchoscope is too large to reacha target location deep in the lungs, a locatable guide (“LG”) envelopedby a sheath is often utilized to navigate from the end of thebronchoscope to the target location. That is, the LG, together with anavigation system, enables the position and orientation of the LG to betracked as the LG is advanced through the airways.

In use, the LG/sheath combination is inserted through the workingchannel of the bronchoscope and into the patient's airways. Once the LGhas been navigated to the target location, aided by the position andorientation tracking provided by the navigation system, the LG isretracted through the sheath, leaving the sheath in position. With theLG retracted, the sheath is often referred to as an extended workingchannel (“EWC”) because it effectively functions as an extension of theworking channel of the bronchoscope.

Once the LG has been retracted from the EWC, the EWC may be used as anavenue for guiding working tools, e.g., biopsy tools, ablation probes,etc., to the target location. However, once the LG is removed from theEWC, tracking is no longer provided and, thus, the operator is operatingblind, relying on the EWC to remain fixed at the target location.Repositioning of the working tool at the target location is likewiserequired to be performed without guidance.

SUMMARY

A system for performing a surgical procedure provided in accordance withthe present disclosure includes a bronchoscope, monitoring equipmentcoupled to the bronchoscope, a tracking system, a positioning assembly,and a biopsy tool. The biopsy tool includes an elongated flexible bodyextending from a proximal end to a distal end and a biopsy member formedon a distal end of the elongated flexible body. The biopsy memberincludes a tissue-receiving portion defining an opening includingsharpened edges. The sharpened edges are disposed on the interiorperimeter of the opening and are capable of cutting tissue.

In aspects, the biopsy member includes a sensor assembly including atleast one location sensor. The location sensor is configured to enabledetection of a location of the sensor assembly within a patient'sairways.

In some aspects, the system includes a computer configured to executesoftware to facilitate navigation of a EWC to a target.

In certain aspects, the opening includes first and second longitudinallyextending faces. The first and second longitudinally extending faces aredisposed on either side of the opening and are angled inwardly andtowards one another to define an acute interior angle therebetween. Eachface includes a sharpened cutting edge disposed on either side of theopening and are positioned such that the sharpened cutting edgesincreasingly approximate one another in a distal to proximal directionculminating at an apex joint.

In aspects, the biopsy member defines a body separate from the elongatedflexible body of the biopsy tool. The biopsy member is secured to thedistal end of the elongated flexible body.

In some aspects, the biopsy member defines a generally hollow interior.The hollow interior is in fluid communication with the opening of thetissue receiving portion of the biopsy member.

In certain aspects, the biopsy tool is configured to connect to a vacuumsource capable of applying suction at the biopsy member.

In aspects, the opening of the tissue receiving portion of the biopsymember is configured to capture tissue of a patient when the vacuumsource is applied to the biopsy tool.

In some aspects, the tracking system includes a tracking module, aplurality of reference sensors, and a transmitter mat.

In certain aspects, the positioning assembly includes a locatable guide,an extended working channel, and a handle. The locatable guide includesa steerable distal tip and a sensor disposed within the distal tip. Thelocatable guide and the extended working channel are dimensioned forinsertion through a working channel defined through the bronchoscope.

According to another aspect of the present disclosure, a biopsy toolincludes an elongated flexible body defining a distal end. The distalend includes a biopsy member including a tissue-receiving portion. Thetissue-receiving portion defines an opening including sharpened edgesdisposed on the interior perimeter of the opening capable of cuttingtissue.

In aspects, the biopsy member includes a sensor assembly including atleast one location sensor. The location sensor is configured to enabledetection of a location of the sensor assembly within a patient'sairways.

In some aspects, the opening includes first and second longitudinallyextending faces disposed on either side of the opening. The first andsecond longitudinally-extending faces are angled inwardly and towardsone another to define an acute interior angle therebetween. Each faceincludes a sharpened cutting edge disposed on either side of theopening. The first and second faces are positioned such that thesharpened cutting edges increasingly approximate one another in a distalto proximal direction culminating at an apex joint.

In certain aspects, the biopsy tool includes a proximal handle portioncoupled to a proximal end of the elongated flexible body. The proximalhandle portion is configured for manual manipulation to drive rotationof the screw member.

In aspects, the biopsy member defines a generally hollow interior. Thehollow interior is in fluid communication with the opening of the tissuereceiving portion of the biopsy member.

In some aspects, the biopsy tool is configured to connect to a vacuumsource capable of applying suction at the biopsy member.

In certain aspects, the opening of the tissue receiving portion of thebiopsy member is configured to capture tissue of a patient when thevacuum source is applied to the biopsy tool.

In aspects, the tissue receiving portion is defined by one or moreplates.

In some aspects, the distal end of the biopsy member defines a generallyblunt configuration.

In certain aspects, the biopsy member defines a body separate from theelongated flexible body of the biopsy tool which is fixedly securedthereto.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects and features of the present disclosure are describedhereinbelow with references to the drawings, wherein:

FIG. 1 is a perspective view of a system provided in accordance with thepresent disclosure configured for navigating a biopsy tool to a targetlocation and obtaining a tissue sample using the biopsy tool;

FIG. 2 is a side view of a biopsy tool, provided in accordance with thepresent disclosure and configured for use with the system of FIG. 1,showing a bronchial aspiration attachment including an extended workingchannel and biopsy catheter;

FIG. 2A is a side view of the biopsy tool of FIG. 2;

FIG. 3 is a perspective view of the distal end of a biopsy tool providedin accordance with the present disclosure and configured for use withthe system of FIG. 1;

FIG. 3A is a side view of another biopsy tool provided in accordancewith the present disclosure and configured for use with the system ofFIG. 1;

FIG. 3B is an enlarged view of the area of detail of FIG. 3A;

FIG. 3C is a top view of the biopsy tool of FIG. 3A;

FIG. 3D is an enlarged view of the area of detail of FIG. 3C;

FIG. 4 is a perspective view of the distal end of another biopsy toolprovided in accordance with the present disclosure and configured foruse with the system of FIG. 1;

FIG. 5 is a perspective view of the distal end of yet another biopsytool provided in accordance with the present disclosure and configuredfor use with the system of FIG. 1;

FIG. 6 is a perspective view of the distal end of still another biopsytool provided in accordance with the present disclosure and configuredfor use with the system of FIG. 1;

FIG. 7 is a perspective view of the distal end of still yet anotherbiopsy tool provided in accordance with the present disclosure andconfigured for use with the system of FIG. 1;

FIG. 8 is a perspective view of the distal end of another biopsy toolprovided in accordance with the present disclosure and configured foruse with the system of FIG. 1;

FIG. 9 is a perspective view of a sensor configured for use with any ofthe biopsy tools of the present disclosure;

FIG. 10 is a perspective view of another a sensor configured for usewith any of the biopsy tools of the present disclosure;

FIG. 11 is a perspective view of yet another sensor configured for usewith any of the biopsy tools of the present disclosure; and

FIG. 12 is an exploded, perspective view of a transmitter mat configuredfor use with the system of FIG. 1 for tracking a biopsy tool through apatient's airways.

DETAILED DESCRIPTION

Devices, systems, and methods for navigating a biopsy tool to a targetlocation and obtaining a tissue sample using the biopsy tool areprovided in accordance with the present disclosure and described indetailed below. The various biopsy tools of the present disclosure, forexample, each generally include a flexible body, a biopsy memberdisposed at the distal end of the flexible body, and a sensor assemblyintegrated into the biopsy tool and positioned adjacent the biopsymember. The biopsy member is configured to facilitate obtaining a tissuesample. The sensor assembly enables determination of the currentlocation of the biopsy member, thus facilitating navigation of thebiopsy member to target tissue and/or manipulation of the biopsy memberrelative to target tissue. However, it is also envisioned that thebiopsy member be provided without the sensor assembly, depending on aparticular purpose. Detailed embodiments of such devices, systemsincorporating such devices, and methods using the same as describedbelow. However, these detailed embodiments are merely examples of thepresent disclosure, which may be embodied in various forms.

With reference to FIGS. 1 and 2, a system provided in accordance withthe present disclosure and configured for planning a pathway to targettissue (planning phase), navigating a positioning assembly to the targettissue (navigation phase), and navigating a biopsy tool to the targettissue to obtain a tissue sample from the target tissue using the biopsytool (biopsy phase) is shown generally identified by reference numeral10. System 10 generally includes an operating table 40 configured tosupport a patient “P;” a bronchoscope 50 configured for insertionthrough the patient's mouth into the patient's airways; monitoringequipment 60 coupled to bronchoscope 50 for displaying video imagesreceived from bronchoscope 50; a tracking system 70 including a trackingmodule 72, a plurality of reference sensors 74, and a transmitter mat76; a computer 80 including software and/or hardware used to facilitatepathway planning, identification of target tissue, and navigation totarget tissue; a positioning assembly 90 or 91 including a locatableguide (LG) 92 an extended working channel (EWC) 96; and a biopsy tool100 insertable through the positioning assembly 90, 91 and operable toobtain a tissue sample, e.g., for subsequent diagnostic testing. Theplanning and navigation phases will initially be detailed below,followed by a detailed description of biopsy tools provided inaccordance with the present disclosure and use of such biopsy tools inconjunction with system 10 in performing the biopsy phase.

With respect to the planning phase, computer 80 utilizes computedtomographic (CT) image data for generating and viewing athree-dimensional model of the patient's airways, enables theidentification of target tissue on the three-dimensional model(automatically, semi-automatically or manually), and allows for theselection of a pathway through the patient's airways to the targettissue. More specifically, the CT scans are processed and assembled intoa three-dimensional CT volume, which is then utilized to generate athree-dimensional model of the patient's airways. The three-dimensionalmodel may be displayed on a display monitor associated with computer 80,or in any other suitable fashion. Using computer 80, various views ofthe three-dimensional model may be provided and/or the three-dimensionalmodel may be manipulated to facilitate identification of target tissueon the three-dimensional model and selection of a suitable pathwaythrough the patient's airways to access the target tissue. Onceselected, the pathway is saved for use during the navigation phase(s).

Continuing with reference to FIG. 1, patient “P” is shown lying onoperating table 40 with bronchoscope 50 inserted through the patient'smouth and into the patient's airways. Bronchoscope 50 includes a sourceof illumination and a video imaging system (not explicitly shown) and iscoupled to monitoring equipment 60, e.g., a video display, fordisplaying the video images received from the video imaging system ofbronchoscope 50.

With respect to the navigation phase, a six degrees-of-freedomelectromagnetic tracking system 70, e.g., similar to those disclosed inU.S. Pat. No. 6,188,355 and published PCT Application Nos. WO 00/10456and WO 01/67035, the entire contents of each of which is incorporatedherein by reference, or other suitable positioning measuring system, isutilized for performing registration and navigation, although otherconfigurations are also contemplated. Tracking system 70 includes atracking module 72, a plurality of reference sensors 74, and atransmitter mat 76. Tracking system 70 is configured for use with eitherpositioning assembly 90 or positioning assembly 91, and biopsy tool 100,as detailed below. Positioning assemblies 90 and 91 include a LG 92having a distal tip 93, which may be steerable. Positioning assemblies90 and 91 further include an EWC 96 and a handle 98. LG 92 and EWC 96are configured for insertion through a working channel of bronchoscope50 into the patient's airways (although LG 92 and EWC 96 mayalternatively be used without bronchoscope 50) and are selectivelylockable relative to one another via a locking mechanism 99. Distal tip93 of LG 92 may be configured for steering in any suitable fashion,e.g., using a plurality of steering wires (not shown) coupled betweenhandle 98 and distal tip 93, to facilitate maneuvering distal tip 93 ofLG 92 and EWC 96 through the patient's airways. Alternatively, rotationand translation of handle 120 may facilitate maneuvering of the distaltip 93 of LG 92, and in particular embodiments the EWC 96 may be angledor curved to assist in maneuvering the distal tip 93 through theairways. Sensor 94 is integrated with distal tip 93 of LG 92 and allowsmonitoring of the position and orientation of distal tip 93, in sixdegrees of freedom, relative to the reference coordinate system. Sensor94 of LG 92 may be configured similar to any of the sensors detailedbelow (see FIGS. 6-8).

As shown in FIG. 1, transmitter mat 76 is positioned beneath patient“P.” With additional reference to FIG. 12, an embodiment of the internalconfiguration of transmitter mat 76 of tracking system 70 (FIG. 1) isshown, although other suitable configurations are also contemplated.Transmitter mat 76 is a transmitter of electromagnetic radiation andincludes a stack of three substantially planar rectangular loop antennas77 a, 77 b, 77 c configured to be connected to drive circuitry (notshown). For a detailed discussion of the construction of exemplarytransmitter mats, which may also be referred to as location boards,reference may be made to U.S. Patent Application Publication No.2009/0284255, filed Apr. 2, 2009, the entire contents of which areincorporated herein by reference.

Transmitter mat 76 and the plurality of reference sensors 74 areinterconnected with tracking module 72, which derives the location ofeach sensor 74 in six degrees of freedom. One or more of referencesensors 74 are attached to the chest of the patient “P.” The six degreesof freedom coordinates of reference sensors 74 are sent to computer 80(which includes the appropriate software) where they are used tocalculate a patient coordinate frame of reference. Registration, asdetailed below, is generally performed by identifying locations in boththe three-dimensional model and the patient's airways and measuring thecoordinates in both systems. Further details of such a registrationtechnique can be found in U.S. Patent Application Pub. No. 2011/0085720,the entire contents of which are incorporated herein by reference,although other suitable registration techniques are also contemplated.

In use, with respect to the navigation phase, LG 92 is inserted intopositioning assembly 90, 91 and EWC 96 such that sensor 94 projects fromthe distal end of EWC 96. LG 92 and EWC 96 are then locked together vialocking mechanism 99 (for example). LG 92, together with EWC 96, arethen inserted through bronchoscope 50 and into the airways of thepatient “P,” with LG 92 and EWC 96 moving in concert with one anotherthrough bronchoscope 50 and into the airways of the patient “P.”Automatic registration is performed by moving LG 92 through the airwaysof the patient “P.” More specifically, data pertaining to locations ofsensor 94 while LG 92 is moving through the airways is recorded usingtransmitter mat 76, reference sensors 74, and tracking module 72. Ashape resulting from this location data is compared to an interiorgeometry of passages of the three-dimensional model generated in theplanning phase, and a location correlation between the shape and thethree-dimensional model based on the comparison is determined, e.g.,utilizing the software on computer 80. In addition, the softwareidentifies non-tissue space (e.g., air filled cavities) in thethree-dimensional model. The software aligns, or registers, an imagerepresenting a location of sensor 94 of LG 92 with an image of thethree-dimensional model based on the recorded location data and anassumption that LG 92 remains located in non-tissue space in thepatient's airways. This completes the registration portion of thenavigation phase.

Referring still to FIG. 1, once the planning phase has been completed,e.g., the target tissue has been identified and the pathway theretoselected, and registration has been completed, system 10 may be utilizedto navigate LG 92 through the patient's airway to the target tissue. Tofacilitate such navigation, computer 80, monitoring equipment 60, and/orany other suitable display may be configured to display thethree-dimensional model including the selected pathway from the currentlocation of sensor 94 of LG 92 to the target tissue. Navigation of LG 92to the target tissue using tracking system 70 is similar to thatdetailed below with respect to the navigation of biopsy tool 100 to thetarget tissue and, thus, is not detailed here for purposes of brevity.

Once LG 92 has been successfully navigated to the target tissue,completing the navigation phase, LG 92 may be unlocked from EWC 96 andremoved, leaving EWC 96 in place as a guide channel for guiding biopsytool 100 to the target tissue. Details of various embodiments of biopsytools, along with the use of the same in the biopsy phase, are describedbelow.

Referring now to FIG. 2, in conjunction with FIG. 1, one embodiment of abiopsy tool provided in accordance with the present disclosure forobtaining a tissue sample from the target tissue is shown generallyidentified by reference numeral 100. As detailed below, biopsy tool 100is depicted inserted into navigation assembly 91 and further configuredfor use in conjunction with tracking system 70 to facilitate navigationof biopsy tool 100 to the target tissue and/or tracking of biopsy tool100 as it is manipulated relative to the target tissue to obtain thetissue sample. Although registration and navigation are detailed abovewith respect to LG 92 of positioning assembly 90, 91, it is alsoenvisioned that LG 92 be eliminated and biopsy tool 100 itself isutilized for registration and navigation, similarly as detailed abovewith respect to LG 92.

Biopsy tool 100, as best shown in FIG. 2A, in conjunction with FIGS. 1and 2, generally includes an elongated flexible body 110 and a connector(122) securing the biopsy tool to the handle 120 of the navigationassembly 91. Connector 122 may include a vacuum source connector such asluer lock which fluidly connects the vacuum source to the biopsy tool100. Flexible body 110 is configured to enable insertion of biopsy tool100 into a patient's airways, e.g., through bronchoscope 50 and EWC 96to the target tissue.

With reference to FIG. 3, rigid distal biopsy member 130 includes a baseportion 140, a tissue-receiving portion 150, and a distal end cap 160.Base portion 140 defines a generally cylindrical configuration andhouses a sensor 170. Sensor 170, in conjunction with tracking system 70(FIG. 1), may be employed to enable tracking of biopsy member 130 ofbiopsy tool 100 as biopsy member 130 is advanced through the patient'sairways, as detailed below. Thus, with additional reference to FIG. 1,computer 80, monitoring equipment 60, and/or any other suitable displaymay be configured to display the three-dimensional model and selectedpathway, both of which were generated during the planning phase, alongwith the current location of sensor 170 of biopsy member 130 tofacilitate navigation of biopsy member 130 to the target tissue and/ormanipulation of biopsy member 130 relative to the target tissue. Varioussensors suitable for use with biopsy member 130 for this purpose aredetailed below (see FIGS. 9-11). Alternatively, biopsy tool 100 may notinclude a sensor and, rather, only LG 92 may be utilized for navigationand positioning. Distal end cap 160 of biopsy member 130 defines agenerally blunt configuration. Alternatively, distal end cap 160 may beconfigured to cut or dissect tissue.

Tissue-receiving portion 150 defines a planar surface 153 and an opening152 configured to receive a tissue sample therethrough and into thegenerally hollow interior of biopsy member 130. Opening 152 is definedby first and second longitudinally-extending faces 154, 156. Faces 154,156 are angled into the interior of tissue-receiving portion 150 and areoriented to define an acute interior angle therebetween, e.g., agenerally “V”-shaped configuration. Faces 154, 156 each includes asharpened cutting edge 155, 157, respectively, disposed on one side ofopening 152. Faces 154, 156 are further oriented relative to one anothersuch that edges 155, 157 increasingly approximate one another in thedistal to proximal direction, ultimately culminating at an apex point158 adjacent to proximal shoulder 159. This feature facilitates dynamictissue cutting, as detailed below. Although generally shown as beingformed from a single plate 161, in one embodiment, tissue receivingportion 150 may be defined by two or more plates 161 disposed on baseportion 140. It is contemplated that the two or more plates 161 may bearranged in a planar configuration (i.e., side by side), or stacked oneover the other as detailed hereinbelow.

With reference to FIGS. 3A-3D, an alternate embodiment of biopsy tool100 is shown, generally referred to as 100′. In this embodiment, biopsytool 100′ includes a monolithically formed biopsy member 130′ that isseparate from flexible body 110′. Biopsy member 130′ includes a shoulderportion 180 on a proximal end thereof. The shoulder portion 180 definesa cavity therein such that biopsy member 130′ may be disposed over thedistal end of flexible body 110′. Biopsy member 130′ may be fixedlysecured to the distal end of flexible body 110′ by any suitable means,such as welding, swage fit, adhesives, etc. A base portion 140′ definesa cutout such that an opening 152′ is formed therein. Opening 152′ isconfigured to receive a tissue sample therethrough and into thegenerally hollow interior of biopsy member 130′. A pair of plates 161′,161″ are disposed on an upper surface of biopsy member 130′ in a stackedconfiguration (see FIG. 3D). Plates 161′, 161″ may be fixedly secured tobiopsy member 130′ by any suitable means, such as welding, adhesives,etc. Each of plates 161′, 161″ defines first and second sharpenedcutting edges 155′, 157′. Edges 155′, 157′ are angled into the interiorof tissue-receiving portion 152′ and are oriented to define an acuteinterior angle therebetween, e.g., a generally “V”-shaped configuration.Edges 154′, 156′ are further oriented relative to one another such thatedges 155, 157 increasingly approximate one another in the distal toproximal direction, ultimately culminating at an apex point 158′adjacent to proximal shoulder 159′. This feature facilitates dynamictissue cutting, as detailed below with respect to biopsy member 130.

Referring to FIGS. 1-3, in use, once the planning and navigation phaseshave been completed, and LG 92 removed from EWC 96, biopsy tool 100 maybe inserted through navigation assemblies 90, 91 and bronchoscope 50 tothe target tissue. Sensor 170 of biopsy member 130, in conjunction withtracking system 70, as mentioned above, enables tracking of sensor 170as it is advanced through the patient's airways. Thus, even after biopsymember 130 is extended distally from EWC 96, the position of biopsymember 130 can be tracked, thus permitting navigation of biopsy member130 to and/or manipulation of biopsy member 130 relative to the targettissue to ensure proper positioning of biopsy member 130 relative to thetarget tissue and allowing certain tissue structures adjacent the targettissue to be avoided. Details of tracking and navigating using suitablesensors and tracking system 70 will be described in greater detailbelow, following the description of the various embodiments thereof.

Once biopsy member 130 of biopsy tool 100 is positioned as desired,vacuum source “V” may be activated (e.g., via a syringe, mechanicalpump, etc.) to apply suction at opening 152 of tissue-receiving portion150 of biopsy member 130 to suction tissue into the interior oftissue-receiving portion 150. As a sample of tissue is suctioned throughopening 152, the sample begins to be cut away from laterally surroundingtissue via the urging of tissue into contact with edges 155, 157, e.g.,as a result of the suction force applied to tissue. Once the tissuesample has been at least partially received within the interior oftissue-receiving portion 150, biopsy member 130 may be translateddistally relative to tissue, e.g., via grasping and translating proximalhandle portion 120 distally, such that the tissue sample is completelysevered from surrounding tissue. This severing of the tissue sample isaided by the relative movement of approximating edges 155, 157 and apexpoint 158 relative to and through tissue. Upon receiving and fullyseparating the tissue sample from surrounding tissue, biopsy tool 100may be withdrawn from the patient's airways and the tissue sampleretrieved from biopsy tool 100 for testing. It is also contemplated thatmultiple samples be taken with biopsy tool 100, e.g., at the samelocation or various different locations, prior to withdrawal.

Referring now to FIG. 4, another embodiment of a biopsy tool provided inaccordance with the present disclosure for obtaining a tissue samplefrom the target tissue is shown generally identified by referencenumeral 630. Similarly as detailed above with respect to the previousembodiment, biopsy tool 630 is configured for use in conjunction withtracking system 70 (FIG. 1) to facilitate navigation of biopsy tool 630to the target tissue and/or tracking of biopsy tool 630 as it ismanipulated relative to the target tissue to obtain the tissue sample.

Biopsy member 630 includes a base portion 640, a tissue-receivingportion 650, and a distal end cap 660. Base portion 640 defines agenerally cylindrical configuration and may house a sensor 670. Sensor670 may be configured similarly to sensor 170 (FIG. 3) and, thus, willnot be detailed herein for purposes of brevity. Distal end cap 660 ofbiopsy member 630 defines a generally blunt configuration.Alternatively, distal end cap 660 may be configured to cut or dissecttissue.

Tissue-receiving portion 650 defines a planar surface 653 and an opening652 configured to receive tissue therethrough and into the generallyhollow interior of biopsy member 630. Opening 652 is defined by a one ormore semi-circular faces 654. In one non-limiting embodiment, opening652 is defined by a series of four interconnecting and overlappingsemi-circular faces 654, 656 a, 656 b, 662 a, 662 b, and 663. Faces 654,656 a, 656 b, 662 a, 662 b, and 663 are angled into the interior oftissue-receiving portion. Faces 654, 656 a, 656 b, 662 a, 662 b, and 663each includes a sharpened cutting edge 655, 657 a, 657 b, 664 a, 664 b,and 665 respectively, disposed on one side of opening 652. Faces 654,656 a, 656 b, 662 a, 662 b, and 663 are further oriented relative to oneanother such that a plurality of projections 667, extending towards thecenter of opening 652, are formed at the junction between adjacent faces654. This feature, in conjunction with sharpened cutting edges 655, 657a, 657 b, 664 a, 664 b, and 665, facilitates dynamic tissue cutting,similarly as detailed above with respect to biopsy member 130 (FIG. 3).In one non-limiting embodiment, tissue receiving portion 650 may bedefined by one or more plates 661 disposed between distal end cap 660and proximal shoulder 659.

Biopsy member 630 may be utilized in a similar respect to biopsy member130 (FIG. 3) as detailed above, with the exception of the ability tosever the tissue by translating biopsy member 630 proximally or distallyrelative to the tissue.

Referring to FIG. 5, another embodiment of a biopsy tool provided inaccordance with the present disclosure for obtaining a tissue samplefrom the target tissue is shown generally identified by referencenumeral 730. Biopsy member 730 includes a base portion 740, atissue-receiving portion 750, and a distal end cap 760. Base portion 740defines a generally cylindrical configuration and may houses a sensor770. Sensor 770 is similar to sensor 170 (FIG. 3) and, thus will not bedetailed here for purposes of brevity. Distal end cap 760 of biopsymember 730 defines a generally blunt configuration. Alternatively,distal end cap 760 may be configured to cut or dissect tissue.

Tissue-receiving portion 750 defines a planar surface 753 and an opening752 configured to receive tissue therethrough and into the generallyhollow interior of biopsy member 730. Opening 752 is defined by firstand second longitudinally-extending faces 754, 756, and curvate face762. Faces 754 and 756 are angled into the interior of tissue-receivingportion 750 and are oriented to define an acute interior angletherebetween, e.g., a generally “V”-shaped configuration. Faces 754,756, and 762 each includes a sharpened cutting edge 755, 757, and 763respectively, disposed on one side of opening 752, thereby forming acontinuous cutting edge capable of cutting tissue. Faces 754 and 756 arefurther oriented relative to one another such that edges 755 and 757increasingly approximate one another in the distal to proximaldirection, ultimately culminating at radiused cutting edge 763 adjacentto proximal shoulder 759. This feature facilitates dynamic tissuecutting, similarly as detailed above with respect to biopsy member 130(FIG. 3). In one non-limiting embodiment, tissue receiving portion 750may be defined by one or more plates 761 disposed between distal end cap760 and proximal shoulder 759.

Biopsy member 730 may be utilized in a similar respect to biopsy member130 (FIG. 3) as detailed above to cut tissue.

Referring now to FIG. 6, another embodiment of a biopsy tool provided inaccordance with the present disclosure for obtaining a tissue samplefrom the target tissue is shown generally identified by referencenumeral 830. Similarly as detailed above with respect to the previousembodiment, biopsy tool 830 is configured for use in conjunction withtracking system 70 (FIG. 1) to facilitate navigation of biopsy tool 830to the target tissue and/or tracking of biopsy tool 830 as it ismanipulated relative to the target tissue to obtain the tissue sample.

Biopsy member 830 includes a base portion 840, a tissue-receivingportion 850, and a distal end cap 860. Base portion 840 defines agenerally cylindrical configuration and may house a sensor 870. Sensor870 may be configured similarly to sensor 170 (FIG. 1) and, thus, willnot be detailed herein for purposes of brevity. Distal end cap 860 ofbiopsy member 830 defines a generally blunt configuration.Alternatively, distal end cap 860 may be configured to cut or dissecttissue.

Tissue-receiving portion 850 defines a planar surface 853 and an opening852 configured to receive tissue therethrough and into the generallyhollow interior of biopsy member 830. Opening 852 is defined by a one ormore semi-circular faces 854. In one non-limiting embodiment, opening852 is defined by a series of interconnecting and overlappingsemi-circular faces 854, 856, and 862 arranged in a clover shapedconfiguration. Faces 854, 856, and 862 are angled into the interior oftissue-receiving portion 850. Faces 854, 856, and 862 each includes asharpened cutting edge 855, 857, and 863 respectively, disposed on oneside of opening 852. Faces 854, 856, and 862 are further orientedrelative to one another such that a plurality of projections 867 withcutting edge 868, extending towards the center of opening 852, areformed at the junction between adjacent faces 854, 856, and 862. Thisfeature, in conjunction with sharpened cutting edges 855, 857, and 863,facilitates dynamic tissue cutting, similarly as detailed above withrespect to biopsy member 130 (FIG. 3). Although generally shown as beingformed from a single plate 861, in other embodiments, tissue receivingportion 850 may be defined by two or more plates 861 disposed on baseportion 840.

Biopsy member 830 may be utilized in a similar respect to biopsy member130 (FIG. 3) as detailed above, with the exception of the ability tosever the tissue by translating biopsy member 830 in any direction (e.g.proximally, distally, laterally, diagonally, etc.) relative to tissue.

Turning to FIG. 7, yet another embodiment of a biopsy tool provided inaccordance with the present disclosure for obtaining a tissue samplefrom the target tissue is shown generally identified by referencenumeral 930. Biopsy member 930 includes a base portion 940, atissue-receiving portion 950, and a distal end cap 960. Base portion 940defines a generally cylindrical configuration and may house a sensor970. Sensor 970 is similar to sensor 170 (FIG. 3) and, thus will not bedetailed here for purposes of brevity. Distal end cap 960 of biopsymember 930 defines a generally blunt configuration. Alternatively,distal end cap 960 may be configured to cut or dissect tissue.

Tissue-receiving portion 950 defines a planar surface 953 and an opening952 configured to receive tissue therethrough and into the generallyhollow interior of biopsy member 930. Opening 952 is defined by a distalregion having a large opening 952 a, including smooth walls 956,tapering proximally to a long narrow opening 952 b having a width lessthan that of large opening 952 a and further including a plurality oftines 954 extending towards the center of opening 952. In onenon-limiting embodiment, tines 954 may be oriented such that they extendtowards the center of opening 952 at an angle such they terminate at aproximal position relative to their base. Large opening 952 a may be ofany shape, including, but not limited to, triangular, circular,rectangular, or the like. One non-limiting embodiment of large opening952 a is of a triangular configuration. Long narrow opening 952 b mayinclude parallel walls or walls forming an acute angle terminating withan apex 955 adjacent to proximal shoulder 959. This feature facilitatesdynamic tissue tearing, as detailed below. Although generally shown asbeing formed from a single plate 961, in other embodiments, tissuereceiving portion 950 may be defined by two or more plates 961 disposedon base portion 940.

Biopsy member 930 may be utilized in a similar respect to biopsy member130 (FIG. 3) as detailed above, with the exception of once biopsy member930 of biopsy tool 100 is positioned as desired, vacuum source “V” maybe activated to apply suction at opening 952 of tissue-receiving portion950 of biopsy member 930 to suction tissue into the interior oftissue-receiving portion 950. As a sample of tissue is suctioned throughopening 952, the sample is trapped within long narrow opening 952 be.g., as a result of the suction force applied to tissue. Once thetissue sample has been at least partially received within the interiorof tissue-receiving portion 950, biopsy member 930 may be translatedproximally or distally relative to tissue, e.g., via grasping andtranslating proximal handle portion 120 proximally or distally, suchthat the tissue sample is completely torn or severed from thesurrounding tissue. This tearing of the tissue sample is aided by theplurality of tines 954 which provide a secure grasp on the tissuesample.

Referring now to FIG. 8, yet another embodiment of a biopsy toolprovided in accordance with the present disclosure for obtaining atissue sample from the target tissue is shown generally identified byreference numeral 1030. Biopsy member 1030 includes a base portion 1040,a tissue-receiving portion 1050, and a distal end cap 1060. Base portion1040 defines a generally cylindrical configuration and may house asensor 1070. Sensor 1070 is similar to sensor 170 (FIG. 3) and, thuswill not be detailed here for purposes of brevity. Distal end cap 1060of biopsy member 1030 defines a generally blunt configuration.Alternatively, distal end cap 1060 may be configured to cut or dissecttissue.

Tissue-receiving portion 1050 defines a planar surface 1053 and anopening 1052 configured to receive tissue therethrough and into thegenerally hollow interior of biopsy member 1030. Opening 1052 is definedby a distal region having a large opening 1052 a, including smooth walls1056, tapering proximally to a long narrow opening 1052 b having a widthless than that of large opening 1052 a. Large opening 1052 a may be ofany shape, including, but not limited to, triangular, circular,rectangular, heart or the like. One non-limiting embodiment of largeopening 1052 a is of a heart shaped configuration. Long narrow opening1052 b includes walls forming an acute angle terminating with an apex1055 adjacent to proximal shoulder 1059. This feature facilitatesdynamic tissue tearing, similarly as detailed above with respect tobiopsy member 930 (FIG. 7). Although generally shown as being formedfrom a single plate 1061, in one non-limiting embodiment, tissuereceiving portion 1050 may be defined by two or more plates 1061disposed on base portion 1040.

Biopsy member 1030 may be utilized in a similar respect to biopsy member930 (FIG. 7) as detailed above, with the exception of once biopsy member1030 of biopsy tool 100 is positioned as desired, vacuum source “V” maybe activated to apply suction at opening 1052 of tissue-receivingportion 1050 of biopsy member 1030 to suction tissue into the interiorof tissue-receiving portion 1050. As a sample of tissue is suctionedthrough opening 1052, the sample is trapped within long narrow opening1052 b e.g., as a result of the suction force applied to tissue. Oncethe tissue sample has been at least partially received within theinterior of tissue-receiving portion 1050, biopsy member 1030 may betranslated proximally relative to tissue, e.g., via grasping andtranslating proximal handle portion 120 distally, such that the tissuesample is completely torn or severed from surrounding tissue. Thistearing of the tissue sample is aided by the long narrow opening 1052 bwhich provides a secure grasp on the tissue sample.

Turning now to FIGS. 9-11, in conjunction with FIG. 1, various differentsensors 248, 348, 448 (FIGS. 9-11, respectively) configured for use asthe sensor of any of the biopsy tools detailed herein and/or sensor 94of LG 92 are described. Although each of the sensors 248, 348, 448 aregenerally described as employing a plurality of sensor elements, it iscontemplated that the sensor of any of the biopsy tools detailed hereinand/or sensor 94 of LG 92 may employ any number of sensor elements(e.g., one, two, three, etc.). Therefore, the descriptions to followshould not be construed as limiting, but merely as exemplifications ofparticular embodiments. Referring to FIG. 9, sensor 248 is shown. Sensor248 includes a plurality of field component sensor elements 251 a, 251b, 1252 a, 252 b, 253. Each sensor element 251 a, 251 b, 252 a, 252 b,253 is formed as a coil and arranged for sensing a different componentof an electromagnetic field generated by transmitter mat 76 (FIG. 12).More specifically, first and second pairs of sensor elements 251 a, 251b and 252 a, 252 b are arranged within sensor housing 246 such that therespective elements 251 a, 251 b and 252 a, 252 b of each pair areequidistant from a common reference point 254, while sensor element 253is centered about reference point 254. Although shown in FIG. 9 ascollinearly disposed, other configurations of sensor elements 251 a, 251b, 1252 a, 252 b, 253 are also contemplated. Further, as opposed toproviding five sensor elements 251 a, 251 b, 1252 a, 252 b, 253 whereinsensor element 253 is centered about the reference point 254, sixsensors may be provide, e.g., wherein sensor element 253 is provided asa pair of elements disposed equidistant from reference point 254. Theabove-described configuration of sensor 248 enables transmitter mat 76and the plurality of reference sensors 74 (FIG. 1), together withtracking module 72 and computer 80 (FIG. 1), to derive the location ofsensor 248 in six degrees of freedom, as detailed below, and as furtherdetailed in U.S. Pat. No. 6,188,355 and published PCT Application Nos.WO 00/10456 and WO 01/67035, previously incorporated herein byreference.

With reference to FIG. 10, sensor 348 is shown including two sensorcomponents 351, 353 arranged within sensor housing 346, each component351, 353 including three sensor elements 352 a, 352 b, 352 c and 354 a,354 b, 354 c, respectively. Each sensor element 352 a, 352 b, 352 c and354 a, 354 b, 354 c is configured as a flat rectangular coil, e.g.,including a plurality of turns of conducting wire, bent to define anarcuate shape. As such, the elements 352 a, 352 b, 352 c and 354 a, 354b, 354 c combine to define first and second generally cylindricalcomponents 351, 353. Components 351, 353 are centered about referenceaxis 356 and positioned such that each of elements 352 a, 352 b, 352 cand 354 a, 354 b, 354 c are equidistant from reference axis 356 and suchthat each of elements 352 a, 352 b, 352 c of component 351 are oriented180 degrees offset as compared to corresponding elements 354 a, 354 b,354 c, respectively, of component 353. Thus, similarly as with sensor248 (FIG. 9), sensor 348 enables transmitter mat 76 and the plurality ofreference sensors 74 (FIG. 1), together with tracking module 72 andcomputer 80 (FIG. 1), to derive the location of sensor 348 in sixdegrees of freedom.

Turning to FIG. 11, sensor 448 includes three coils 451, 452, 453. Coils451 and 452, 453 are angled relative to housing 446, while coil 453 iscircumferentially disposed within housing 446. Coils 451, 452, 453 areoriented to lie in perpendicular planes relative to one another andshare a common center reference point 454. By sharing a common centerreference point 454, each portion of each coil 451, 452, 453 isequidistant from center reference point 454. Further, thisconfiguration, e.g., wherein coils share a common center reference point454 rather than being longitudinally displaced relative to one another,allows for the longitudinal dimension of sensor 448 to be minimized.Such a configuration still, however, enables transmitter mat 76 and theplurality of reference sensors 74 (FIG. 1), together with trackingmodule 72 and computer 80 (FIG. 1), to derive the location of sensor 448in six degrees of freedom.

Referring additionally to FIG. 1, the electromagnetic waves generated bytransmitter mat 76 are received by the various sensor elements of thesensor assembly e.g., the sensor elements of sensors 248, 348, 448(FIGS. 9-11, respectively) configured for use any of the biopsy toolsprovided herein or sensor 94 of LG 92, and are converted into electricalsignals that are sensed via reference sensors 74. Tracking system 70further includes reception circuitry (not shown) that has appropriateamplifiers and A/D converters that are utilized to receive theelectrical signals from reference sensors 74 and process these signalsto determine and record location data of the sensor assembly. Computer80 may be configured to receive the location data from tracking system70 and display the current location of the sensor assembly on thethree-dimensional model and relative to the selected pathway generatedduring the planning phase, e.g., on computer 80, monitoring equipment60, or other suitable display. Thus, navigation of the biopsy tooland/or LG 92 to the target tissue and/or manipulation of the biopsy toolrelative to the target tissue, as detailed above, can be readilyachieved.

As used herein, the term “distal” refers to the portion that is beingdescribed which is further from a user, while the term “proximal” refersto the portion that is being described which is closer to a user.Further, to the extent consistent, any of the aspects and featuresdetailed herein may be used in conjunction with any or all of the otheraspects and features detailed herein.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular embodiments.

1-10. (canceled)
 11. A biopsy tool, comprising: an elongated flexiblebody defining a distal end, the distal end including a biopsy member,the biopsy member including a tissue-receiving portion defining anopening including sharpened edges disposed on the interior perimeter ofthe opening, the sharpened edges capable of cutting tissue.
 12. Thebiopsy tool of claim 11, wherein the biopsy member further includes asensor assembly including at least one location sensor configured toenable detection of a location of the sensor assembly within a patient'sairways.
 13. The biopsy tool of claim 11, wherein the opening includesfirst and second longitudinally extending faces, the first and secondlongitudinally-extending faces disposed on either side of the openingand being angled inwardly and towards one another to define an acuteinterior angle therebetween, wherein each face includes a sharpenedcutting edge disposed on either side of the opening, the first andsecond faces being positioned such that the sharpened cutting edgesincreasingly approximate one another in a distal to proximal directionculminating at an apex joint.
 14. The biopsy tool of claim 11, furtherincluding a proximal handle portion coupled to a proximal end of theelongated flexible body, the proximal handle portion configured formanual manipulation to drive rotation of the screw member.
 15. Thebiopsy tool of claim 11, wherein the biopsy member defines a generallyhollow interior, the hollow interior in fluid communication with theopening of the tissue receiving portion of the biopsy member.
 16. Thebiopsy tool of claim 15, wherein the biopsy tool is configured toconnect to a vacuum source capable of applying suction at the biopsymember.
 17. The biopsy tool of claim 16, wherein the opening of thetissue receiving portion of the biopsy member is configured to capturetissue of a patient when the vacuum source is applied to the biopsytool.
 18. The biopsy tool of claim 11, wherein the tissue receivingportion is defined by one or more plates.
 19. The biopsy tool of claim11, wherein a distal end of the biopsy member defines a generally bluntconfiguration.
 20. The system biopsy tool of claim 11, wherein thebiopsy member defines a body separate from the elongated flexible bodyof the biopsy tool, wherein the biopsy member is fixedly secured to thedistal end of the elongated flexible body.
 21. A biopsy tool,comprising: an elongated flexible body extending from a proximal endportion to a distal end portion and defining a longitudinal axistherethrough; and a biopsy member formed on a distal portion of theelongated flexible body and defining a distal end cap having a bluntdistal end portion configured to inhibit the distal end cap from cuttingtissue, the biopsy member including a tissue-receiving portion definingan opening disposed perpendicular to the longitudinal axis, the openingdefining a plurality of semi-circular faces angled into the interior ofthe tissue-receiving portion, each face of the plurality ofsemi-circular faces including a sharpened edge configured to cut tissue.22. The biopsy tool according to claim 21, wherein the biopsy memberincludes at least one location sensor configured to enable detection ofa location of the biopsy member within a patient's airways.
 23. Thebiopsy tool according to claim 21, wherein the biopsy member defines abody separate from the elongated flexible body of the biopsy tool,wherein the biopsy member is secured to the distal end portion of theelongated flexible body.
 24. The biopsy tool according to claim 21,wherein the biopsy member defines a generally hollow interior in fluidcommunication with the opening of the tissue receiving portion of thebiopsy member.
 25. The biopsy tool according to claim 24, wherein thebiopsy tool is configured to connect to a vacuum source configured toapply suction at the biopsy member.
 26. The biopsy tool according toclaim 25, wherein the opening of the tissue receiving portion of thebiopsy member is configured to capture tissue of a patient when suctionis applied at the biopsy member.
 27. A biopsy tool for insertion througha bronchoscope and into a patient's airways, comprising: an elongatedflexible body extending from a proximal end portion to a distal endportion and defining a longitudinal axis therethrough; a biopsy memberformed on a distal portion of the elongated flexible body and defining adistal end cap, the distal end cap defining a blunt distal end portionto inhibit the distal end cap from cutting tissue, the biopsy memberincluding a tissue-receiving portion defining an opening disposedperpendicular to the longitudinal axis, the opening defining a pluralityof semi-circular faces angled into the interior of the tissue-receivingportion, each face of the plurality of semi-circular faces includingsharpened edges capable of cutting tissue; and at least one locationsensor coupled to the biopsy member and configured to enable detectionof a location of the biopsy member within a patient's airways.
 28. Thebiopsy tool according to claim 27, wherein the biopsy member defines abody separate from the elongated flexible body of the biopsy tool,wherein the biopsy member is secured to the distal end portion of theelongated flexible body.
 29. The biopsy tool according to claim 27,wherein the biopsy member defines a body separate from the elongatedflexible body of the biopsy tool, and the biopsy member is secured tothe distal end portion of the elongated flexible body.
 30. The biopsytool according to claim 27, wherein the biopsy member defines agenerally hollow interior in fluid communication with the opening of thetissue receiving portion of the biopsy member.